- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Medical Devices
Recipient NameMichael Mainelli
Recipient TitleChief Executive Officer
- Stanmore Implants Worldwide Ltd.
210 Centennial Avenue
- Issuing Office:
- Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Mr. Mainelli:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case #444402), issued on November 26, 2014. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
CAPT Raquel Peat, PhD, MPH, USPHS
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
cc: Establishment File
Home District of Corporate HQ (or of receiving firm if issued by a Center)
FOI Office for Posting
CMS case file (electronic copy)